Surpass Elite FDSE52525Recalls & reported problems
Stryker Corporation · Flow Diverter System · Class 3 · Implant
All models of Surpass Elite (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327583281), received between Dec 23, 2025 and Dec 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Failure” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
Patient problems
- Paralysis1
- Stroke/CVA1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE STENT WAS FLATTENED, AND THE MID-SECTION OF THE STENT DIDN'T OPEN COMPLETELY. THE CLOT WENT DISTAL AND MAY RESULTED IN A STROKE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Paralysis; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 23879076 ↗
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- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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